Forum Markets, Incorporated · NASDAQ:FRMM
Forum Markets — CannBioRx Life Sciences — SPAC Merger (December 2019)
41 slides from Forum Markets's SPAC merger presentation, Dec 12, 2019
Slide 1: Corporate Presentation December 2019
CORPORATE PRESENTATION DECEMBER 2019 1 1
Slide 2: Disclaimer
2 DISCLAIMER 2 This Presentation is for informational purposes only and does not constitute an offer to sell, a solicitation of an offer to buy , or a recommendation to purchase any equity, debt or other financial instruments of CannBioRx Life Sciences Corp. (“CannBioRx”) or KBL Merger Corp. IV (“KB
Slide 3: Inflammation drives the world's biggest diseases
INFLAMMATION DRIVES THE WORLD’S BIGGEST DISEASES The experienced and world - renowned scientific team are proven leaders in this field. • Sir Marc Feldmann: Centocor sold to J&J for $4.9 B USD • Lawrence Steinman: Tysabri sold to Royalty Pharma for $2.85 B USD • Jonathan Rothbard: Amylin sold to Ast
Slide 4: CannBioRx Highlights
4 CANNBIORX HIGHLIGHTS 4 4 • Scientific team and founders are pioneers with proven track record in drug discovery from the University of Oxford, Hebrew University and Stanford University • Developing three families of novel drugs addressing significant market opportunities in inflammation, fibrosis
Slide 5: Co-founders and management
5 Mr George Hornig COO & Acting CFO Dr Marlene Krauss CEO CO - FOUNDERS AND MANAGEMENT 5 Dr Jonathan Rothbard CSO Prof Jagdeep Nanchahal CMO Prof Raphael Mechoulam Founder, CBRx Prof Sir Marc Feldmann Co - Chairman Prof Lawrence Steinman Co - Chairman • Pioneer of anti - TNF therapy, world’s biggest
Slide 6: Three platform technologies
6 FIBROSIS & ANTI - TNF (CLINICAL STAGE)* SYNTHETIC CBD ANALOGS (SCAs) a 7nAChR TECHNOLOGIES Repurposing of anti - TNF for major unmet needs, other patented drugs Novel non - psychoactive synthetic CBD analogs Novel α7 nAChR agonists TARGETED DISEASES NEAR TERM • Early stage Dupuytren’s disease (DD)
Slide 7: Three platform technologies targeting multiple indications
α7nAChR • Smoking cessation induced ulcerative colitis SCAs • Chronic pain • Early arthritis PLATFORM INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Fibrosis & Anti - TNF * • Dupuytren’s contracture • Frozen shoulder • PO C D • NASH Est. start Q1 2023 Est. start Q3 2022 Est. start Q2 2020 Est. start
Slide 8: Fibrosis & Anti-TNF Program
FIBROSIS & ANTI - TNF PROGRAM O xf o r d CLINICAL STAGE LEAD PROGRAM Targeting common diseases - facilitates trials and potential sales 8 Led by Profs Jagdeep Nanchahal & Sir Marc Feldmann, Oxford Dr Glenn Larsen, USA Clinical trials supported by Prof Sallie Lamb, UK
Slide 9: Fibrosis & Anti-TNF Platform
FIBROSIS & ANTI - TNF PL ATFORM Developing targeted therapies for: » Early Stage Dupuytren’s disease (DD) - patent issued; Phase 2b/3 results expected Q1/2 2021* » Frozen shoulder - patent issued; clinical trials projected in Q4 2020 » Post operative cognitive decline (POCD) - patent issued, clinica
Slide 10: Unique Competitive Advantage
10 UNIQUE COMPETITIVE ADVANTAGE # 1 • Working with disease experts and key opinion leaders, who are highly motivated to improve patient standard of care • No payment for trial patients required in the UK/EU • Easier recruitment. Access to large registries of patients/diseases • Staff costs can be co
Slide 11: Unique Competitive Advantage: human disease tissue
11 UNIQUE COMPETITIVE ADVANTAGE # 2 Studies in DD lead the way for novel approach to develop clinical programs in other fibrotic diseases: • All fibrosis preceded by inflammation, involves myofibroblasts • Our targets identified in patient myofibroblasts and associated immune cells • Using human tis
Slide 12: TNF/TNFR2 signaling activates Wnt pathway in fibrosis
12 TNFR2 cell membrane extracellular intracellular Anti - TNF *Use - of patent issued for DD, patent pending for unique delivery system, current program TNF Anti - TNFR2 mab * patent pending, future program TNF Wnt activation leading to FIBROSIS (↑ expression of a - SMA, Col1A1 genes etc ) UNEXPECTE
Slide 13: Initial indication targeting Dupuytren's disease
13 INITIAL INDICATION TARGETING DUPUY TREN’S DISEASE • C ommon localized fibrotic condition of the hand , develops over years • Nodules form under skin – eventually creating a thick cord pulling one or more fingers • Can limit hand functions • Unlike liver and lung fibrosis can be identified early E
Slide 14: Phase 2a completed: adalimumab is effective
Anti - Tumour Necrosis Factor Therapy for Dupuytren’s Disease: A Randomised Dose Response Proof of Concept Phase 2a Clinical Trial Jagdeep Nanchahal 23,* , Catherine Ball 23 , Dominique Davidson 24 , Lynn Williams 23 , William Sones 25 , Fiona E McCann 23 , Marisa Cabrita 23 , Jennifer Swettenham 23
Slide 15: Phase 2b/3 trial fully enrolled
15 • Randomized blinded trial in patients with early DD injected with optimal dose adalimumab * • Every 3 months for 1 year (4 injections), following for a total of 18 months • Outcome measures include nodule hardness, size and disease progression • Randomized 181 patients across 3 sites in UK and t
Slide 16: Large market opportunity for early Dupuytren's disease
16 Estimated future worldwide market for Dupuytren’s >$1B per year (1) All current treatments for Dupuytren's are for LATE stage disease • 4% of the EU & US population suffer from Dupuytren’s disease ( 1,2) • Assume ~25% of these (1% total) are symptomatic & require treatment (3) Potential patients
Slide 17: Additional indications: Post operative cognitive deficit
ADDITIONAL INDICATIONS: 17 • Over 300,000 hip fractures each y ea r in the U.S. alone 1 • Strong pre - clinical and clinical evidence for anti - TNF as preventative therapy • Patent claims granted, patent is licensed from Kennedy Trust, UK • Phase 3 multi - centre trial of pre - operative anti - TNF
Slide 18: Evidence that TNF plays a role in POCD
18 • Mice subjected to surgery (open tibial fracture) experience a rapid increase in plasma TNF levels (A) - not caused by anesthesia alone (B) • Administration of pre - operative anti - TNF reduces freezing behavior, indicative of contextual fear memory, characteristic of cognitive decline (C) • Su
Slide 19: Additional fibrotic indications continued
ADDITIONAL FIBROTIC INDICATIONS CONTINUED : • Painful inflammatory condition that progresses to scarring, limiting movement • Affects 9% of the of the population aged 25 - 64yr, more common in diabetics 1 • Only treatment for early stage is local steroid injection for short term relief • Phase 2 cli
Slide 20: Next generation therapeutics: anti-TNFR2 & anti-IL-33
NEXT GENERATION THERAPEUTICS: ANTI - TNFR2 & ANTI - IL - 33 INHIBITORS 20 20 Soucre for Diagram Above: Izadi D et al. Sci. Adv. 2019; 5 : eaay0370 4 December 2019 – supp data Dupuytren’s disease fibrotic nodules comprise myofibroblasts and immune cells (macrophages and mast cells mostly) Proposed me
Slide 21: Fibrosis & Anti-TNF clinical development plan
FIBROSIS & ANTI - TNF CLINICAL DEVELOPMENT PLAN * 2 0 20 2 0 21 2 0 2 2 2 0 23 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Anti - TNF DD phase 2b/3 trial 21 Ph 2b results P h 3 results Q4 2026 POCD results Frozen Shoulder (FS) Preparation POCD Preparation Approval to do trial** Anti - TNF FS
Slide 22: Synthetic CBD Analogs (SCAs)
SYNTHETIC CBD ANALOGS (SCAs) 22 Jerusalem, Israel Led by Profs R Mechoulam, R Gallily, A Domb, A Hoffman – HU, Jerusalem Prof Sir Marc Feldmann, Prof R Williams, Dr L Topping – Oxford Clinical trials supported by Prof Sallie Lamb, UK
Slide 23: SCAs for unmet needs in pain and inflammation
Synthetic CBD analogs (SCAs) for unmet needs in pain and inflammation 23 • Safe & non - psychoactive • Formulated to offer improved oral bioavailability (> three - fold) • Rigorously tested in clinical trials for inflammatory pain (efficacy and dosing) • Granted market approval by FDA, EMA and other
Slide 24: SCA platform description
• Non - psychoactive CBD analogs (SCAs) are anti - inflammatory, and elicit analgesic effects • Studied by Mechoulam, Gallily, Feldmann since 1998 ( Malfait et al, PNAS 2000) PLATFORM DESCRIPTION * Patented drug we licensed from HU, but expect to discover superior drugs from ongoing research ** CBD
Slide 25: Problems with medical marijuana / OTC CBD and our solution
× Variable composition, potency, and may contain undesirable contaminants x We will use SYNTHETIC >99.5% pure SCAs 25 • CBD and CBD - PNL administered orally to rats & plasma l evels assessed over time • CBD - PNL >3x absorption compared to CBD alone • CBD - PNL safe and well tolerated • Additional
Slide 26: CBD: a superior treatment for arthritis
CBD - A SUPERIOR TREATMENT FOR ARTHRITIS CBD reduces inflammation in knee arthritis – unpublished new data PROBLEM • Very early arthritis, pain & swelling is not effectively treated clinically • Nonsteroidals do not help, can increase TNF 1 • Existing therapies are suboptimal: • Methotrexate has sid
Slide 27: SCA Pipeline
SCA PIPELINE * 2020 2021 2022 2023 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Development of l ead SCA Phase 1 Phase 2a/b Indication tbc R e s ul t s 27 R e s u l t s SCA pipeline Phase 2a/b in early arthritis Therapeutic development of SCA 2 Preclinical development of SCA 2 Indication tbc *Bas
Slide 28: α7nAChR Program
α7 n ACh R PROGRAM 2 8 California, USA Prof L Steinman & Dr J Rothbard Supported by Evotec, US 28
Slide 29: Why develop α7 agonists for inflammation?
• Decade of research on immune suppression in multiple sclerosis led to realization of the importance of the a 7 subunit of nicotinic Acetylcholine Receptor ( nAChR ) • a 7 nAChR also a central factor in evolutionarily ancient neural circuit to control of inflammation 1&2 • Large pharma identified a
Slide 30: α7 agonist development strategy
3 0 CHEMISTRY • Synthesize patentable, orally bioavailable α7 agonist • Chemically modify known agonist to retain/improve anti - inflammatory activity • Retain CNS penetration Bioassays • Inhibition of TNFα & IL6 secretion after stimulation with LPS in cell lines and primary cells • Stimulation of C
Slide 31: Significant unmet need: existing therapies are sub-optimal
3 1 Significant Unmet Need Existing Therapies Are Sub - Optimal Existing Therapy Issues Anti - inflammatory drugs (5 - aminosalicylates, corticosteroids) × capability to induce remission is quite low × known deleterious side effects of steroids Immunosuppressants × long - term administration of thio
Slide 32: α7 nAChR platform, a novel therapeutic platform for UC
3 2 Faster Time to Market Lower Development Costs Targeted Clinical Trial Novel Therapeutic Target Significant Unmet Need Repurposing drugs previously proven safe (targeted Alzheimer’s & Schizophrenia) Drugs stimulate vagal nerve, leading to localized anti - inflammatory response, similar to nicotin
Slide 33: α7nAChR Pipeline
3 3 *Based on current proposals. No regulatory approvals obtained from appropriate authorities at this time. 2020 2021 2022 2023 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Pre - clinical efficacy α7nAChR pipeline Lead identified Lead optimisation Clinical development For smoking cessation induc
Slide 34: Conclusion
34 CONCLUSION 34 • Scientific team and founders are pioneers with proven track record in drug discovery from the University of Oxford, Hebrew University and Stanford University • Developing three families of novel drugs addressing significant market opportunities in inflammation, fibrosis and pain:
Slide 35: CannBioRx Life Sciences Corp
CANNBIORX LIFE SCIENCES CORP Registered Address 1201 Orange Street Suite 600 Wilmington, DE 19801 USA 35
Slide 36: Appendix
36 APPENDIX
Slide 37: Fibrosis program patents (1 of 3)
FIBROSIS PROGRAM PATENTS ( Pg 1of 3) METHOD OF TREATING EARLY STAGE DUPUYTREN'S DISEASE Country Application No. C&D Docket No. Status Australia 2017248273 8554 - A - PCT - AU Application pending in Australian Patent Office Canada 3,020,327 8554 - A - PCT - CA Application pending in Canadian Patent O
Slide 38: Fibrosis program patents: treatment for Dupuytren's disease
FIBROSIS PROGRAM PATENTS TREATMENT FOR DUPUYTREN’S DISEASE Country Application No. C&D Docket No. Status Australia 2011322482 90330 - A - PCT - AU Australian Patent No. 2011322482, granted July 20 , 2017 Australia 2017204267 90330 - AZ - PCT - AU Australian Patent No. 2017204267, granted September 1
Slide 39: Fibrosis program patents (3 of 3)
FIBROSIS PROGRAM PATENTS METHOD OF TREATING LOCALIZED FIBROTIC DISORDERS USING AN IL - 33/TNF BISPECIFIC ANTIBODY Country Application No. C&D Docket No. Status U.S. 16/328,979 87158 - F - PCT - US Filed February 27, 2019. Europe 17924768.9 87158 - F - PCT - EPO Filed April 1, 2019. METHOD OF TREATIN
Slide 40: SCA program patents
SCA PROGRAM PATENTS Cyclohexenyl compounds, compositions comprising them and uses thereof Country Application No. Status Activity expected Comments US2 10239848 Granted Maintenance due by September 21, 2022 Claims directed to a method for treating obesity or a disease/disorder associated therewith b
Slide 41: α7nAChR program patents
α 7 n ACh R PROGRAM PATENTS 41 Country Application No. Priority Date Description US Application US20180333451A1 B - 1a lymphocyte and/or macrophage targeting and activation to treat medical conditions with inflammatory or autoimmune components Japan 2018 - 526196 2015 - 11 - 18 Canada 3004908 US Gra
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